The cost to Pharma of outdated processes: 9 things to consider for review
Sep 6, 2023
Medical information is constantly changing. Due to inefficient processes when working with this information, Regulatory Affairs and Medical Information functions may often find themselves unnecessarily stretched.
Datapharm's CEO, Rich Cooper, outlines 9 key areas when working with this information which are worth considering for optimisation.
In an era of rapid information changes, the pharmaceutical industry cannot afford to rely on outdated processes.
Working in the regulatory and compliance environment is challenging for a variety of reasons, but can pharmaceutical companies really afford to be spending so much effort on these tasks?
Here are just a few of the examples we’ve seen in recent times.
1. Publishing medicines information in-house may not be in the best interests of your audience
Creating your own Pharma website, especially for distributing information to a large audience, requires considerable resource and budget. Further to this, with medicines information we should be asking; is there a risk of missing your audience, in turn compromising patient safety?
2. Getting our heads in a muddle around spreadsheets
For many Pharma professions, document management is a part of everyday life, with stringent measures in place to show to the auditor what has been recorded. But using spreadsheets for these responsibilities (monitoring document uploads, for example) brings a number of difficulties. This includes: security; risk of data corruption; loss of time due to manual input; and risk of inaccurate information due to human error.
It is often the case that spreadsheets are seen as the easiest or most obvious option – the reality is, there are better and much safer options available for auditing purposes.
3. PDFs – are they just the digital equivalent of printed copy?
The internet, for all its wonders and privileges, has given the world relatively free reign over publishing content online. It’s because of this that PDFs in particular show greater risk than standard webpages (html format) for medicine safety information, as PDFs can be easily downloaded, redistributed and published literally anywhere, therefore increasing the risk of out-of-date information in circulation.
4. Waiting for the form to be completed
Even large Pharma companies are challenged with a lack of standardisation when dealing with customer accounts. This often involves the customer receiving a form to complete and send back to the supplier, but if you’ve ever dealt with document forms, you will know how unintuitive this is. A better solution would be to have a single portal to fill in and share this information.
5. Tracking the medicines information changes
When a change to medicine information is published, this triggers a string of communications with relevant stakeholders, often referred to as the SmPC broadcast. Some external stakeholders require these changes in a tracked changes format for visibility over what has actually changed, however this is a long and laborious process and lacks a single source of truth to refer back to.
6. SmPC broadcasts
The SmPC broadcast is a crucial cog in the regulatory information management process. Because there are so many stakeholders involved in medicine information change updates, this can often cause a duplication in submission or communication of information.
7. Republishing of medicines information
In UK healthcare, there are a variety of channels on which to publish your medicines information, but this process shouldn’t need to be repeated. Customers publishing their information on emc are already distributing it through to millions of HCPs across the UK healthcare ecosystem.
For Pharma, it’s crucial to show the auditor that you have appropriate internal measures in place, for example, processes to ensure that the latest medicine safety information is shared effectively. Our analysis found that in some cases, up to 18% of SmPC updates had not been downloaded by the sales representative.
With emc compliance, companies know exactly which representatives to follow up with, and which products are concerned – the importance of this is highlighted by the fact that 95% of our emc compliance customers make use of this functionality.
9. Reporting of returned paper RMMs as a measure of effectiveness for RMM campaigns
In the UK, distribution of RMMs (Risk Monitoring Measures) is a legal obligation, though in its current form it is a significant cost to the industry that they have to be sent as hard copy. This could be impacting thousands of GPs within the NHS, while the surveys used to measure their impact have to be filled in by hand.
A digital solution would not only be better for the environment, but can arguably improve visibility on the impact of these RMMs.
As well as product information management, getting compliance processes right is a key challenge for the Pharmaceutical industry and, most importantly, benefits patient outcomes enormously.
At Datapharm we are aiming to address and find solutions for the aforementioned challenges as we continue to support Pharma’s management and distribution of their medicines information.